Canon Aplio Ultrasound Systems Software Defect May Misassign Patient Images
Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a software defect that could result in patient images being lost or misassigned to wrong medical records. No illnesses or injuries have been reported, but the potential for diagnostic errors and treatment delays represents a significant risk-of-harm scenario.
Plain-English summary
Canon Aplio ultrasound systems (Models Aplio i900, i800, i700, a550, and a450) manufactured by Canon Medical System, USA, INC. are subject to a Class II recall due to a software defect in the Stress Echo protocol.
If the Stress Echo protocol is not manually terminated by the user, it may fail to end automatically. During the next patient's examination, an abnormal confirmation message appears asking whether to use an image saved from the previous examination phase. Depending on the user's response, either acquired images may not be saved or images may be assigned to the wrong patient's medical record.
This malfunction could result in lost or misassigned patient imaging data, potentially delaying diagnosis and treatment. The recall affects 65 ultrasound systems distributed across multiple U.S. states.
Affected healthcare facilities should contact Canon Medical System, USA, INC. for corrective measures.
The recalled product
- Product
- Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
- Manufacturer
- Canon Medical System, USA, INC.
- Hazard
- software-defect
- patient-data-misassignment
- image-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Model/UDI-DI
- with software: Aplio i900 TUS-AI900/ 04987670102523
- Aplio i800 TUS-AI800/ 04987670102516
- Aplio i700 TUS-AI700/ 04987670102509
- With System Version:V4.6/V5.0/V5.1
- SP0005 to SP1014
- or V6.0/V6.5 SP0000 to SP1009
- Aplio a550 CUS-AA550/ 04987670103353
- Aplio a450 CUS-AA450/ 04987670103346
- With System Version: V3.0
- or V4.0/V4.5
- SP0000 to SP1009
Distribution
Distributed in 23 states:
- AR
- CA
- CO
- FL
- GA
- IA
- IL
- KS
- KY
- LA
- ME
- MI
- MN
- MO
- MT
- NC
- NY
- OK
- PA
- SC
- TN
- WA
- WV
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